BEUDAMED
    Product Code: HGC FDA class 1 21 CFR 884.4520

    Clamp, Uterine

    Obstetrics/Gynecology

    The Uterine Clamp is a surgical instrument used to compress or occlude the uterus or uterine blood vessels during gynecological operations to control bleeding or secure tissue. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HGC, regulated under 21 CFR 884.4520, within the Obstetrics/Gynecology specialty. No special risk flags apply.

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    510(k)s
    2
    FEI Numbers
    69
    Registration Numbers
    69
    Unique Applicants
    2
    Years Active
    12

    Basic Information

    Product Code
    HGC
    Device Class
    FDA class 1
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K891402 UTERINE CLAMPS
    K771344 GUSBERG HYSTERECTOMY CLAMP

    FEI Numbers

    This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.